A Study To Evaluate The Dose Response And Safety Of PHA-794428 In Adults With Growth Hormone Deficiency

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Growth Hormone Deficiency

Treatments: Drug: PHA-794428

Study type: Interventional

Funder types: Industry

Identifiers

NCT00308464

A6391003

Details and patient eligibility

About

The purpose of this study is to explore the safety, toleration and dose response of PHA-794428 after multiple weekly injections in male and female growth hormone deficient patients.

Full description

The study terminated on 10-Dec-2007. Pfizer's decision to terminate the program was due to cases of injection-site lipoatrophy that were reported in the clinical Phase 2 studies after a single injection of PHA 794428.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients with severe AGHD.
• Hypopituitary patients must be on adequate hormone replacement therapy for at least 6 months.

Exclusion criteria

• AGHD patients with uncontrolled pituitary tumor growth.
• Tumors within 3 mm of the optic chiasm.
• Patients with diabetes mellitus.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind